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Intellectual Property Issues for Scientists
• It is impossible to copyright a scientic law.
• Patenting an abstract concept is impossible.
In the European Union, software cannot be patented as a standalone entity. Patents are granted
only to “computer- implemented inventions,” which are dened as software programs performing
innovative and benecial functions within a patented hardware system.
Countries such as Japan, India, and South Korea typically align with the EU’s stance, allowing
software patents solely as part of a physical invention. China previously held a similar position on
software patents. However, newly introduced patent review rules indicate a shift in China’s perspective, showing a growing inclination towards patenting software as an independent entity. The State
Intellectual Property Ofce (SIPO) of China has guidelines permitting the patenting of both storage
mediums and computer program executions. Some researchers suggest that these two components—
storage devices and software— may be individually patentable.
14.4.6 Medical Method Patents
In the United States, a medical procedure qualies for a patent if it meets three criteria:
• Specicity: It is detailed enough to reveal its aws.
• A way of treating a specic condition with a specic medication is referred to as a practical
application.
• It has a primary transformative effect, meaning it fundamentally changes the goal’s nature.
The European Patent Ofce (EPO) approves medical technique patent applications if they are
novel, creative, and don’t involve surgery, therapy, or diagnostics. Denying patents for medical,
pharmaceutical, and diagnostic processes aims to relieve clinicians of the fear of inadvertently
infringing on a patent while treating a patient.
Japan, akin to the EPO, approves medical patents unless they obstruct the practices of physicians.
China has allowed pharmaceutical patents since 1992. Surprisingly, Chinese examiners don’t seek
a patent claim adhering to approved medical technique standards. Instead, they maintain a database
of non- patentable medical operations. South Korea does not accept patents for medical procedures.
India also disqualies such patents, prohibiting methods for human or animal treatments that render
them disease- free.
14.4.7 business Methods Patents
In the United States, business process patents have been granted since 1988, but the Alice judgment
casts uncertainty on their future validity. For a business method to be patented, it must generate a
“useful, measurable, and observable outcome” with real- world value— not merely a theoretical or
investigational procedure.
Running a specic hardware system or device combination in an obvious, current, and inventive
manner falls within patentable bounds.
Japan allows the patenting of business processes applied using hardware, while China does not.
South Korea protects novel technologies enhancing the technological aspects of automated systems.
However, India doesn’t permit the patenting of business processes.
14.4.7.1 Utility Model in the European Union
• A utility model, similar to a patent, safeguards tinventions. Although many nations offer
this protection, the United States, the United Kingdom, and Canada don’t provide utility
models. Utility models are akin to patents but are typically more affordable to obtain and
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maintain. They usually have shorter durations (6 to 15 years), quicker grant times, and fewer
patentability requirements. They are applicable only to specic technologies in certain countries, often referred to as second- class patents.
• Unlike copyright or trademark treaties, no international treaty mandates utility model protection. Yet, the Paris Convention covers them under the Protection of Industrial Property. This
mandates adhering countries to rules like national treatment and priority. Utility models can
also be accessed through the Patent Cooperation Treaty (PCT) for foreign patent applications
in countries with utility model systems.
• Utility models grant a statutory exclusive right for a limited time in exchange for providing
sufcient information for an ordinary person in the related eld to replicate the invention.
Utility model laws grant privileges similar to those granted by patent laws, but they are
more suited to “incremental inventions.” A utility model is a “right to prohibit anyone from
commercially using a protected invention without the permission of the right holder(s) for a
limited period.”
• Various terms such as “petty patent,” “innovation patent,” or “minor patent” describe utility
models. The “Gebrauchsmuster” from Germany and Austria has inspired similar models in
countries such as Japan.
• Many countries with utility model rules require novelty in technology. However, some ofces
do not conduct substantive reviews and grant utility models based only on meeting formal
requirements. This process is often termed “utility model registration.” Certain subject matters
like methods (processes), chemical substances, plants, and animals may be exempted from
utility model protection in some countries.
• In the EU, innovation can also be protected under utility models
• IP right with a territorial registration.
• Only in a few countries is it available.
• In Europe, there is no central ling.
• Up to 10 years of defense.
• Only some countries have a search report after a few months, it was registered and released.
• In most cases, there is no in- depth investigation (novelty, inventiveness, industrial applicability).
• Only invalidation or violation cases are checked.
• The following are some of the methods for safeguarding the utility model:
• Contractual obligations.
• Job arrangements with restrictive covenants.
• Non- disclosure agreements (NDAs).
• Convenient “Need to know” knowledge is only available to a limited number of people.
• Encryption is the process of encrypting data.
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14.4.8 PRovisional aPPlication
In the United States, a provisional application for patent may be led, providing extensive
details about the invention, though not to the same extent as a standard (or non- provisional)
application. Within one year, a regular patent application based on the provisional application
must be led.
A provisional application establishes an earlier registration date for an innovation than the nal
date of patent issue for a regular application. Unlike a regular utility patent, a provisional patent
expires within a year and does not commence a 20- year patent term.
Provisional applications are primarily led to establish priority dates when urgently needed.
Reasons for ling a provisional application include overall reduced expenses and a shorter waiting
period for patent issuance (prosecution only begins upon the utility application). Under US patent
law, a provisional application can be upgraded to a utility patent application.
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A disclosure document serves as proof of concept for a new idea or product. It should not replace
a provisional or standard utility patent application. Filing a standard patent application within
two years of receiving the disclosure document at the USPTO allows the applicant to establish a
registered proof of the date of conception for a fee of USD 10. However, unlike a Provisional submission, the date of the Disclosure Document cannot be used as an effective ling date. Due to the
earlier ling date it offers, most intellectual property ofces prefer the Provisional application over
the Disclosure Document.
14.5 COMPARISON OF PATENT LAWS
14.5.1 juRisdiction
A patent in the United States doesn’t grant the holder an absolute right to utilize the creation. Under
35 USC 271(a), the patent owner has the right to prevent others from making, using, selling, or
importing the patented invention.
Patents are limited to specic territories and must be applied for in the country where protection
is desired. A U.S. patent solely safeguards an inventor’s rights within the United States, necessitating separate patent applications in other countries or regional patent ofces for international
protection. Virtually every country has its own patent laws, requiring individuals seeking patents in
multiple countries to adhere to each country’s regulations.
Patent rules in many nations differ from those in the United States in a variety of ways. In most
foreign countries, publicizing an innovation before the ling date can invalidate the right to a patent.
Maintenance expenses are typically mandatory, and many countries demand the technology’s production within their borders after a specied period. Failure to produce may invalidate the patent in
certain countries. Additionally, providing obligatory licenses to any patent applicant is possible in
many countries.
14.5.2 the Patent cooPeRative tReaty
To secure coverage in a particular jurisdiction, it is imperative to hold a patent awarded by
that country. Consequently, many new patent applications are submitted under an international
agreement that allows countries to pool patent applications. PCT Learning Center (http:// www.
pctlea rnin gcen ter.org/ ) is a non- prot organization that educates people about PCT. The Patent
Cooperation Treaty, or PCT, is an international treaty that controls the ling of patent applications
in 117 nations. Although the PCT scheme does not grant foreign patents, its primary aims are to
streamline the process of ling in multiple countries, defer costs associated with seeking international patent protection, and afford inventors more time to assess the commercial viability of
their inventions.
Submitting a PCT application doesn’t mean ling separate applications in each covered country.
The invention must be independently led in each jurisdiction, adhering to their regulations.
Though PCT application standards mirror those for US patent applications, each country has unique
requirements. Filing fees for PCT applications are substantial, and additional fees are due for each
foreign nation ling. Moreover, patent claims accepted in different countries may vary.
Signed in June 1970 and effective from January 24, 1978, the Patent Cooperation Treaty has
been ratied by over 160 countries, including the United States (as of May 2, 2020). The treaty
streamlines ling procedures and offers a common application format, making it easier for member
countries to le patents for the same invention. Upon timely foreign application ling, the applicant
receives an international ling date in each covered country, an invention search, and an extended
deadline for national patent applications. Many patent attorneys specialize in obtaining patents
abroad. Seeking treaty immunity within one year of ling in the US allows up to 30 months to le
in other signatory nations.
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For inventions originating in the United States, prior permission from the Director of the USPTO
is necessary before applying for patents in other nations. A license grant is mandatory unless a ling
receipt with a license grant has been provided earlier. This requirement applies when an overseas
application is submitted before a U.S. application or before the six- month period following the
U.S. application ling expires. Upon ling a patent application, a license request is made, and its
approval or denial is indicated on the ling receipt sent to each applicant. Unless the innovation has
been classied as secret, a license is unnecessary after 6 months from the ling date in the United
States. However, if an order of secrecy has been granted for the invention, the USPTO Director’s
consent is required for ling outside the United States while the secrecy order is in effect.
14.5.3 fiRst- to- invent Rule
In the US, the patent is granted to the rst inventor who conceives and implements the innovation,
be it a functional prototype or a well- dened concept. Conversely, other countries adhere to the
rst- to- le rule, awarding the patent and all rights to the rst person to submit a patent application
for an invention.
Clause 101 of US Code 35 states, “Whoever invents or discovers any new and useful technique,
system, manufacturing, or composition of matter, or any new and useful improvement thereof, may
acquire a patent therefor…”
On January 1, 1996, Clause 104 of US Code 35 was amended to permit World Trade Organization
member countries to utilize the “rst to invent” approach in determining innovation precedence in
the United States.
One way to establish the date of invention is through the inventor’s logbook. Ideally, the inventor’s
logbook should be a distinct book or a collection of highlighted pages or entries in a continuous
laboratory notebook. It should contain detailed records of ideas, test ndings, and other aspects of
the invention process. Look for pre- printed numbered pages, non- fading backgrounds, spaces for
signing and dating by the inventor and a witness. Avoid using loose- leaf notebooks, 3- ring binders,
taped- together legal pads, or notepads. Opt for a notebook with bound or sewn- together pages. The
binding ensures that, in the event of a valid patent dispute, it can be proven that the notebook record
was not added or backdated later.
14.5.4 fiRst- to- file Rule
In cases where two individuals apply for a patent on the same invention, the patent is awarded to the
person who led their application rst (assuming the invention is patentable). This holds true even if
the second person created the invention rst. The ling date is the decisive factor. In 2013, the United
States adopted the rst- to- le system. Under this system, the rst applicant has a prima facie claim
to the patent. However, if two parties claim the same invention under the rst- to- invent scheme, the
USPTO will conduct an interference proceeding to evaluate evidence regarding creation, reduction
to practice, and diligence. This process of interference is time- consuming and costly.
If the technology was publicly available before the patent application was led, the application
may be rejected. “Publicly accessible” refers to selling the idea, giving a talk about it, displaying
it to an investor without a non- disclosure agreement (NDA), publishing it in a journal, etc. It
doesn’t matter whether the disclosure was made by the inventor, a neutral third party, or another
individual.
In the United States, there exists a one- year grace period (35 US Code section 102). This means
that the inventor can publish their innovation without fear of losing the patent. However, this rule
only applies within the United States. If an inventor does so, they forfeit all future European patent
rights (as well as rights in many other countries worldwide). This grace period is effectively limited
under the Leahy- Smith America Invents Act to publications made by the inventor or those who
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directly obtained the inventor’s knowledge. A third- party publication might jeopardize the novelty
of the innovation (though this is debatable and may require legal resolution).
Article 30 of the Japan Patent Act provides a six- month grace period for disclosures made by
experiments, publications, presentations at study conferences, exhibitions (trade fairs or the World’s
Fair), or if the invention becomes publicly known against the applicant’s will. These types of
disclosures are not considered prior art. This exemption is signicantly broader than that provided
by European patent law (Article 55 EPC) but narrower than that offered by US patent law.
In Japan, the person who rst applies for a patent for an invention is entitled to obtain the patent,
not necessarily the individual who rst invented the same thing. Existing inventions do not receive
exclusionary protection under Japanese patent law, as they do in other countries. Article 29(1) of the
Patent Act stipulates that an inventor may not obtain a patent for inventions that were publicly used
(“publicly used”) (Item ii), or inventions that were described in a distributed publication or made
available via electronic communication in Japan or abroad.
14.5.5 best Mode ReQuiReMent
According to US patent law (35 US Code section 112), the inventor must disclose the best mode
for carrying out the patent application. This prevents the inventor from obtaining a patent while
concealing an essential or valuable feature. Failure to include the best mode before the Leahy- Smith
America Invents Act could result in the invalidation of the patent. Even though this Act is no longer
in force, it still must be formally included.
Contrary to US law, European patent law (Article 83 EPC) doesn’t contain such a clause. It
requires that the proposal includes at least one method of carrying out the invention, although this
method doesn’t necessarily have to be the best one.
14.5.6 Patent Publication
Public disclosure, making copies available to the public, is mandatory for most plant and utility patent
applications. Patent applications are also published by the World Intellectual Property Organization
(WIPO) and the United States Patent and Trademark Ofce (USPTO). When ling a U.S. plant or
utility application, the applicant can request non- publication if the invention has not been or will not
be part of a foreign application necessitating publication 18 months after ling or under the PCT.
Both the USPTO and WIPO/ PCT publish patent applications 18 months after the applicant’s
earliest successful ling date or priority date. Once a patent application is published, the US Patent
and Trademark Ofce (USPTO) and the World Intellectual Property Organization (WIPO) no longer
keep it condential. Any member of the public can request access to the entire le history of the
application.
Until 2001, patents in the United States were only issued upon obtaining them. Unless withdrawn or accompanied by a non- publication order stating that the application is solely for the United
States, US patent applications are now published 18 months after submission.
This is similar to the European approach, where all patent applications are published 18 months
after ling unless they are withdrawn. If the novelty search has been completed by that time, the
search report is published along with the application.
Filing a patent application doesn’t determine the patentability of the invention; it simply indicates
that the application has been open for 18 months. People familiar with the US system, which only
publishes granted patents, may mistake anything published by the EPO as a granted patent.
The distinction between a patent application and a granted patent can be seen in two ways.
A publication with a “A” in the top- right corner denotes an application, while a “B” indicates a
granted patent. Additionally, European patents that have been granted do not have an abstract on the
front cover.
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As a result of publication, an applicant can claim provisional rights. These rights enable a
patentee to sue a third party who infringes on a claim in a published application for lawful royalties. Consequently, anyone who infringes on one or more claims of the invention before the patent
is granted can face penalties.
14.5.7 Rights confeRRed
A US patent is a legally enforceable property right in the United States. It grants the patent holder
the authority to prevent others from making, using, or selling the patented invention within the
United States. This holds true due to the federal statute outlined in the US patent law (35 US Code).
In contrast, the European Patent Convention (EPC) stands as a treaty signed by 27 European
countries, including Austria, Belgium, Bulgaria, Switzerland, Cyprus, the Czech Republic,
Germany, Denmark, Estonia, Spain, Finland, France, Greece, Hungary, Ireland, Italy, Liechtenstein,
Luxembourg, Monaco, the Netherlands, Portugal, Romania, Slovenia, Slovakia, Sweden, Turkey,
and the United Kingdom. The EPC patents are issued by the European Patent Ofce (EPO),
headquartered in Munich.
For the chosen nations within the EPC, a European patent issued under the EPC bestows the
same rights as a national patent. Essentially, a European patent represents a compilation of national
patents. After obtaining a European patent, it can only be invalidated in each selected country.
Anyone can le an opposition with the EPO for the rst nine months after the patent is awarded to
have the patent canceled in all of these countries at the same time.
14.5.8 oPPosition afteR gRant
Anyone can le an opposition with the EPO within nine months of the issuance of a European
patent, arguing why the patent should not have been granted (as expected, with arguments and evidence). After that, the patent holder and the opponent will debate each other. Finally, the EPO will
decide based on all parties’ evidence and arguments.
Typically, the parties involved present their cases during Oral Proceedings held at the EPO in
Munich following the submission of their arguments in written form. Although the EPO generally
reaches a nal decision during these hearings, the proceedings may continue in written form. Both
parties have the right to appeal the ruling, which entails further exchanges of letters and the possibility of additional Oral Proceedings.
In the United States, while there exists a re- examination procedure, it lacks the efcacy of the
opposition process. In a re- examination, any individual may challenge the validity of a granted
patent by presenting reasoning and facts to the USPTO. However, in this process, the patent holder
engages in discussions with the USPTO examiner to assess the validity of the arguments, while the
challenger remains uninvolved.
The Leahy- Smith America Invents Act introduced an “inter partes” review where the challenger
participates in the hearing. The continuation of this investigation remains uncertain.
14.5.9 inventive steP
Two primary requirements under European patent law demand that an invention be both patentable and novel, as well as inventive (Article 52 EPC). This aligns with similar criteria in the US,
where innovation must be novel and non- obvious (35 US Code sections 102 and 103). The Patent
Cooperation Treaty species that innovation must be both original and inventive, streamlining the
ling process across participating nations. Notably, being non- obvious is sufcient to necessitate a
creative step.
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Contrarily, the EPO adopts a more stringent approach. A European patent application is deemed
inventive if it addresses a technical challenge in a non- obvious manner. It’s crucial to highlight two
additional requirements: the invention must present a solution to a technical problem (lack of a
problem solved implies no inventive step), and the problem must be technical (solving purely economic issues lacks an inventive step).
The process of determining a technical issue involves establishing the novelty of the invention.
Once established, the closest prior art document, sharing the most features with the invention or
most closely resembling it in some manner, is selected. Then, the differences are assessed to identify
the problem that the invention resolves.
For instance, if the technological challenge is to enhance a driver’s visibility in low- light settings,
and the innovation pertains to a bike equipped with a reector while the closest prior art is a bike
without lights, the issue is rectied by attaching a reector to the bike. This enables other road users
to see the driver in the dark due to the reected light.
The subsequent query revolves around whether the solution to a technological problem would
be obvious. Adding a headlight to enhance visibility, akin to vehicles or signal towers, is a common
choice. A professional can conventionally install a headlight on the bike. Consequently, the answer
to the obviousness question would be negative, necessitating a creative phase in the innovation
process.
It’s essential to note that in patent law, the terms “qualied individual” and “obvious” hold distinct meanings compared to everyday usage.
Additionally, the determination of a technical issue doesn’t occur retrospectively. Initially, when
confronted with an invention, the initial perception might be that it’s obvious because the solution
appears naturally apparent. However, this perception doesn’t reect the effort required to actualize
the invention. Consider a scenario where everyone settles for a mediocre solution (e.g., a bike with a
headlight powered by human effort through a dynamo). Recognizing that a particular method would
be desirable in such a situation can be considered innovative.
For a patent to be granted in Japan, it must rst hold industrial relevance. Article 29(1) of the
Patent Act in Japan species that innovations involving genes, chemical substances, or species must
identify a concrete, appropriate usage. The term “industry” encompasses manufacturing, agricultural, shing, forestry, mining, commercial, and service industries but excludes medical enterprises.
Consequently, patents for medical care discoveries aren’t accepted as they lack industrial signicance. This prohibition is grounded in the ethical principle that patent rights shouldn’t restrict the
diagnosis and treatments available to medical practitioners caring for patients. While there’s no
explicit constitutional provision barring patent rights for medical care acts, patent rights can be
obtained for medical practice elds such as drugs, medical equipment, and their manufacturing,
with pharmaceutical patents subject to certain limitations under Article 69(3) of the Patent Act.
14.5.10 tWo- PaRt claiM
European patents and applications frequently utilize two- part claims, initiating with a list of traits
followed by the phrases “characterized in that” or “with an augmentation containing,” and additional
attributes. These latter characteristics dene the innovation (often termed characterizing features).
The prior art encompasses the rst two qualities.
In the scenario of submitting an application for a single- part allegation, the Examiner may
suggest delimiting the argument from the closest prior art (text most similar or sharing the most
features with the invention).
Conversely, one- part claims are almost always present in US patent applications and patents.
If a US patent contains a two- part argument, it is likely held by a European corporation. In the
US, utilizing two- part claims places anything before the characterizing portion within prior art
(also known as “Jepson claims” after the rst patent attorney to use them). If a novel feature is
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erroneously included in the pre- characterizing part, it is deemed prior art, potentially jeopardizing
patentability.
Consider a scenario where an applicant includes a feature in the pre- characterizing section not
found in the closest prior art in Europe. In such cases, relocating the feature to the characterizing
section sufces. This situation commonly arises when the applicant initially begins with a document designated as the closest prior art. However, during review, it’s determined that another text
represents the closest prior art, necessitating an amendment. Nonetheless, this typically doesn’t
impact patentability signicantly.
14.6 PATENT ASSIGNMENT
Transferring or selling a patent is akin to selling a house; the patent no longer belongs to the original
owner. Licensing a patent, however, is akin to renting a home; if the licensee breaches the terms,
eviction follows.
In patent law, a written agreement known as an “assignment” facilitates the transfer or sale of a
patent, passing the full interest in the patent to the assignee. Consequently, the assignee becomes the
patent owner, enjoying identical rights as the original patentee. Partial interest in a patent, such as
half, fourth, or fth interest, can also be assigned, often related to specic aspects of the invention
or certain application areas.
The US Patent Ofce maintains records of assignments, grants, and similar instruments, providing public notice. If a patent or interest in a patent remains unassigned, granted, or conveyed
within three months after documentation at the US Patent Ofce, subsequent buyers cannot claim
ownership.
Patent licensing and joint ownership offer alternatives. Joint inventors or assignees of a portion
interest in a patent can hold patents jointly. Each joint owner, regardless of their ownership share,
has rights to create, use, offer for sale, sell, and import the invention independently of other joint
owners. They can sell their stake or grant patent licenses without needing approval from other joint
owners.
When a licensee signs a patent licensing agreement, the Licensor agrees not to sue the licensee
for patent infringement. This agreement can take any written form containing mutually agreed
terms, including royalties.
14.7 PATENT INFRINGEMENT
According to patent law, transferring or selling a patent involves a written agreement called an
“assignment,” which transfers the full interest in the patent. Once the patent is given to the assignee,
they become the patent owner and possess the same rights as the original patentee. Patent law
permits the assignment of a partial interest in a patent, such as half, a quarter, or a fth. Assignments
can relate to specic aspects of an invention or certain application areas.
The US Patent Ofce records assignments, awards, and similar documents, serving as formal
notication. If a patent or interest in a patent (or a patent application) isn’t transferred, granted,
or conveyed within three months after the transaction at the US Patent Ofce, subsequent buyers
cannot claim ownership.
Patent licensing and joint ownership are viable options. When a patent is shared among joint
inventors or a portion of a patent is assigned, it can be owned by multiple individuals. As long as
they don’t infringe on others’ patent rights, each joint owner has the right to use, sell, import, or
offer the invention for sale, regardless of their share. They can also sell their stake or grant patent,
regardless of how little their portion of ownership, may create, use, offer for sale, sell, and import the
invention for prot. Without regard for the other joint owners, they may sell the stake or any portion
of it, or grant patent licensing to others.
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A patent licensing agreement involves the Licensor pledging not to sue the licensee for patent
infringement. It doesn’t have a set format and is a written agreement incorporating terms agreed
upon by the parties, such as royalties.
14.8 BIOLOGICAL PATENTS
Gene patenting raises ethical concerns in bioethics. Three main arguments against genetic patenting
exist: ethical objections to treating life as a commodity, the argument that living elements cannot be
patented as they are naturally occurring, and concerns that patenting genetic material could compromise the integrity of human and other species by allowing external ownership of their genes.
International agreements such as the Agreement on Trade- Related Aspects of Intellectual Property
Rights (TRIPS) mandate intellectual property protection for most biological inventions, making outright bans on gene patents unlikely for many governments.
The usage of gene patents ethical use of gene patents post- issuance is a signicant concern. Patent
owners’ restrictions might make utilizing proprietary products and processes extremely expensive
or even impossible. Furthermore, considering the vast markets for these goods, the innovators construct a wall around their composition patent in order to prot well beyond the initial exclusivity
period, innovators often build barriers around their patented composition, contradicting the fundamental purpose of patents to benet humanity until expiration.
In Australia, patents on naturally occurring DNA sequences are valid.
In the United States, natural biological compounds (along with related methods or uses) sufciently “isolated” from their natural state can be patented. Previous patents on adrenaline, insulin,
vitamin B12, and various genes exemplify this. However, the United States Supreme Court reached
an opposing conclusion in a landmark ruling in June 2013, stating that naturally occurring DNA
sequences are not eligible for patents, unlike the stance taken by the European Patent Organization,
which allows protection for such sequences if they are “isolated from [their] natural environment or
generated using a technological approach.” However, the United States Supreme Court concluded in
a landmark ruling in June 2013 that naturally occurring DNA sequences are not patentable.
European patents cannot be granted for treatments that require the termination of human embryos,
according to the European Patent Ofce.
In the case of Diamond v Chakrabarty (447 US 330; 1980), the Supreme Court ruled that discoveries involving live organisms altered by humans were eligible for patents. The Court’s interpretation of section 101 expanded the scope, providing the embryonic biotechnology industry with the
impetus to begin and drive an intense period of growth.
Biotechnology patent claims, like all invention claims, delineate a patentee’s enforceable rights.
Failing to offer the widest claim breadth could pose a signicant obstacle for a patentee defending
their rights. Considering the critical role of claims in understanding and utilizing patent rights effectively, it’s worth exploring how claims function in the biotechnology eld to protect breakthroughs.
Imagine a scenario where a patent claim, though broad, is poorly worded and rejected due to formal
defects; this leaves the patentee with a defense scope barely larger than the actual developed protein species. Competitors can then make minor adjustments to circumvent the literal meaning of
the claims. According to the Federal Circuit, the purpose of claims is to determine the enforceable
breadth of patent rights. For patents to continue fostering innovation, they must continue fullling
this role.
The counterparts’ theory, on the other hand, provides a reasonable foundation for discouraging
the alleged infringement by preventing minor alterations to evade the claim. In exceptional cases,
it seems reasonable for a patentee with excessively narrowed protein patent claims to bypass the
limitations imposed by the literal scope of the claims, safeguarding against “the unscrupulous
copyist” who makes insignicant changes and substitutions in the patent that add nothing substantial (Graver Tank, 339 U.S. at 607).
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Before 1995, the expiration dates of various biotech invention components could be years apart.
Most patents now expire 20 years after ling in the US, unless extended due to ofce or regulatory
delays or pediatric exclusivity extensions.
14.8.1 Monoclonal antibody technology
Biotechnology medications are derived from the immune system’s processes that produce white
blood cells, known as lymphocytes. In the thymus gland, these cells originate as stem cells in
the bone marrow, then differentiate into B- lymphocytes (B- cells) or T- lymphocytes (T cells). Bcells’ primary role is to create antibodies in response to encountering foreign materials through
interactions with B- cell surface receptors. Following activation, the activated B cell rapidly divides,
generating an identical clone of plasma cells that release antibodies with the same antigen specicity
as the original B cell. Antibodies, also referred to as immunoglobulins or Ig molecules, are intricate
proteins with antigen- binding sites on their branches, resembling the structure of the letter Y. These
antibodies attach to antigen molecules, forming a cross- linked, insoluble complex that prevents the
spread of the antigen. Antigens are proteins located on the surface of invading cells, like bacteria.
When antibodies bind to the cell’s surface, it exposes them to macrophages and other immune
system components (opsonization).
Antibodies isolated from human blood, specically immunoglobulin- G (IgG or gamma- globulin),
have long been used to treat viral infections. The efcacy of these antibodies varies based on the recentness of the donor’s infection. They can also serve in disease diagnosis and distinguishing between
biological species. Hybridoma lines were initially included in patent disclosures because early
inventions were unable to characterize the amino acid sequence in antibody molecules. However, as
more sophisticated methods became available, antibody sequencing replaced or supplemented cell
line deposits. Characterizing antibody amino acid sequencing enabled the production of antibodies
using recombinant DNA methods. A concern with clinical use of monoclonal antibodies was the
potential interaction of mouse proteins, after repeated injection, with the patient’s immune system,
reducing their potency or potentially inducing a severe allergic reaction. To address this, antibodies
produced by recombinant (rDNA) methods used chimeric MAbs with murine variable regions (Y
arms), while the constant portions (the Y’s base) remained human. Another technological advance
replaced all hypervariable regions with specicity, resulting in a humanized antibody.
Further technological advancements allowed segments of antibody genes to be produced on a
carrier’s surface, like a bacteriophage. This approach enabled the selection of hypervariable sections
of specic specicity, combining them into genes that can be expressed to produce entirely human
monoclonal antibodies. However, by the time the rst of these medications entered the market, the
technology for chimeric and humanized antibodies had become obsolete. Phage display also aids in
discovering compounds, large or small, that bind to a given structure, such as a receptor or its ligand.
Antibodies with unique properties often serve as catalysts, facilitating processes by maintaining two
reagent molecules in the correct conformation.
Claims to the nucleic acid encoding the antibody protein, vector constructs, cell lines harboring
vectors expressing the protein, methods of harvesting the antibody, purifying the protein from cell
line components, formulation for administration, and the device for antibody administration can all
protect a monoclonal antibody product.
14.8.2 antisense technology
If the genetic code of a disease- causing gene is identied, it could be entirely avoided. Genes consist
of double- helical DNA. When a gene is activated, the genetic code in that DNA portion is transcribed
as messenger RNA (mRNA). mRNA, often called a “message” sequence, can be translated into
amino acids to create a protein. In a DNA double helix, the “antisense” strand is the complementary
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